Cleared Traditional

K243339 - WiTOF

K243339 is an FDA 510(k) clearance for WiTOF, manufactured by Idmed. The device is a Class 2 Anesthesiology device with product code KOI cleared through the Traditional 510(k) pathway after a 241-day FDA review.

K243339 · Idmed · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2025
Decision
241d
Days
Class 2
Risk

K243339 is an FDA 510(k) clearance for the WiTOF. Classified as Stimulator, Nerve, Peripheral, Electric (product code KOI), Class II - Special Controls.

Submitted by Idmed (Marseille, FR). The FDA issued a Cleared decision on June 23, 2025 after a review of 241 days - an extended review cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.2775 - the FDA anesthesiology and respiratory device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Anesthesiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Idmed devices

FDA 510(k) Submission Details - K243339

510(k) Number K243339 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 25, 2024
Decision Date June 23, 2025
Days to Decision 241 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
101d slower than avg
Panel avg: 140d · This submission: 241d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KOI Device Classification - Class 2, Special Controls

Product Code KOI Stimulator, Nerve, Peripheral, Electric
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.2775
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Anesthesiology devices follow this clearance model.

Regulatory Peers - KOI Stimulator, Nerve, Peripheral, Electric

All 22
Devices cleared under the same product code (KOI) and FDA review panel - the closest regulatory comparables to K243339.
TetraGraph Neuromuscular Transmission Monitor (SEN 2015)Accessories:TetraSens (SEN 2012)TetraSens Pediatric (SEN 2013)TetraSensitive (SEN 2016)TetraHub (SEN 2017)
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iTOF®
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Neuromuscular Transmission Monitor TOF3D
K212434 · MIPM Mammendorfer Institut f?r Physik und Medizin GmbH · May 2022